AU2008269683B2 - Use of estriol in low doses - Google Patents

Use of estriol in low doses Download PDF

Info

Publication number
AU2008269683B2
AU2008269683B2 AU2008269683A AU2008269683A AU2008269683B2 AU 2008269683 B2 AU2008269683 B2 AU 2008269683B2 AU 2008269683 A AU2008269683 A AU 2008269683A AU 2008269683 A AU2008269683 A AU 2008269683A AU 2008269683 B2 AU2008269683 B2 AU 2008269683B2
Authority
AU
Australia
Prior art keywords
estriol
dose
day
use according
administration
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
AU2008269683A
Other versions
AU2008269683A1 (en
Inventor
Alvaro Acebron Fernandez
Dolores Blanco Lousame
Jaime Moscoso Del Prado
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ITF Research Pharma SL
Original Assignee
ITF Research Pharma SL
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ITF Research Pharma SL filed Critical ITF Research Pharma SL
Publication of AU2008269683A1 publication Critical patent/AU2008269683A1/en
Application granted granted Critical
Publication of AU2008269683B2 publication Critical patent/AU2008269683B2/en
Assigned to ITF RESEARCH PHARMA, S.L.U. reassignment ITF RESEARCH PHARMA, S.L.U. Request for Assignment Assignors: ITALFARMACO, S.A.
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/30—Oestrogens

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Urology & Nephrology (AREA)
  • Reproductive Health (AREA)
  • Diabetes (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Use of low doses of estriol via the vagina for treatment and/or prevention of urogenital atrophy due to oestrogen deficit in women.

Description

USE OF ESTRIOL IN LOW DOSES 33vgnl ro w i h peoto 'nd/o the K Kneh a o' 3' <K 0gW''<' '33'KK' ' I''' ''3a w r y is K 3 '''y' '3 ' tK aK g}' a3Mr'gVIn 1macterAc t e e i pa"'3' K t'K;' '1;no o 2K re 31K; r 3: an e ia uoa K' K a p y v c s w n. nw3 eas 'K cKI~ f I c 1 33hra V K? ki'3'' '''' 3 3 'K th q 33lk at life's o 3 33, wo an is K 3 2' u K' d eK 33 K 3 3 K' iK t3 'l Kc l 3n vile33 '3nI d &ISO1 inK -tp r3 O t mKn su3h as 1h _- .,e .. J '33'nva 3t o h s als 3, 1 ,3n' <2" ' 35 ~ ~~~~~~~~~~~ <K n lc -. t cuay wt o ta w 3'~n 3 U K'' e') of 3 e ur th 3K'''f 3,3'_ 31 '' "''' 3' 2 cadoasua .?:s n -ysn te rsk OF ulferlSA Due>3 0 0 LIMM aS a S CO 9 edn c03 31.5923. andl patientsfl" "'3' cninu3ous~cl.y demaL3 y1,. in'> or'j case of Yot'a 9>2333321 3'3 L e : . 3.'' m3 s 3A0A3 by'A' '' 'ACL is' 220 1> ay n310Q03.A.. ''K S~ aiv i t h 1diita o of KSr n by vagna rout. However,37 '3) YOU'A nt riskfre sinc 1 o, a.' I l3 A 1.3 1onono could~ '''14 on unane enfltria Qnl 3 jai~ MCA3A'3> K thi hyeplsa inK> the eyn W Di osdeal, ol deeea' in , cancer.. 9 Es3'o A<3'3 cuo }F :he estrgen 1 t3, uroanta au*3:ph1' ;',r:>3tiw'.e. W sdoe i h vni cn iAW~ unnecessary{ cc Menow in G A c 1-nion th <''33' ,.n-n 'K o- 31-yond 3, c, n" ---~ ~ ~ ~ A- -- -- -- --. .. .... on C~ 3 as 0( V' e'. s '73 C1 e0 '3', s ro , ca 33:J m ~ SCC 1 r''> a3'' ' rA i ( rio1 for':n e,, i n a_:,/ of urgeit l <'tt9<"' whc pivd boL sa<e' <' and A.i 3i 3or < ce e by dotos n j3 it/ 3' rt3 A"'su tn i raw, 35 e' t~ fl<33> f ,i r,- Oe -aL n ec S CO e' t K 0 e c tt . s' a t ~~~~~r-. ' 0 'iic > t n t ' t t; c tha 2 - z t i t i es 1ia All ' 10 '2 if a iti fo 'Iqna $W Or~ o the pre, i ""' 't('i c Ci of -Ur t t] a7> .4' 42 c" 1 V' jt n I en n W sai /.I ;Adn Ii. "'c at cistne ci- th t W tot rve v ............ It t ...... ................ c fl lt a i. F, -r-'' v 'tf o I- t' h, ''f~c~ 'i - I i cu4in n 'w>'il I s an''' act vc ca bioC- " tPl > "cici'''ll&Iy lot dose an '1 i' IF Lc [vi' OlV V ci vt~i- '- Pitt or ,- C>n r x n -- n c;n r s m ' l 'k .' dC'" a ,h7' ' _"1 An r"oKan .4...".h ~eet varKLo s Cseial lo doe of VanI whc on 10 nd K tv 3oml U r deie C n Me ivnioai wih ay fetv fan' th ra metC'rbjn nla ro ' a ~ ~ ~ ~ 4 patcua ..7 e t. eatril i di ~ rd i oe eg tn r eul t . atro<tK. 110 1, ~ef rre elSCI MIviL rV.01"n U kio 'Is Cf estr'' indoesle' Another C' ""'A''l in'; do e we .0 w Mohr n4rr.J use~~~~~~~~~~~~A mTati!i oe O mo,0 2adK w d.10ai Xg/aA) 20 Surprisingly, when u~ing e w Q i uh o cn M, daily andfo> Phs-e Migades of the regimen O~~~~~Fadiitain o sr-1 W 1e vs m p 3vry a ''m " th 7' ml o lgm lalaauh sever al il lustrativwe examples of the invention are described below. In no case mst they be considered an 1 initing for the interpet Exaroles The ficc o the use of low doses of estrial in th, treatnr&n of- urogenital atrophy in hw hog h olwn in vivo asscvs, 10 Two fannulations worn rested in ti tdec fte containing 0.005% (W/w) of estrial. To dissolve nhe active ingredient, a stocksouon f estriol in glycerin. was pmeparec. 00T that en d, 25 mg of 15 owa, stirred for hour and the complete dissolutimn ofesio was verified, To prepare the foriBulal-W'1 tin cram WErmulatwor 1' , on one hand 20 q of Neo PCL o/w self-eusivna bas inanetnl aqueous phase were heated at V54C under magnetic stirring, 20 whramo h thrhnd4 fn o ronopol wredisvdin7 under continuous stirring, the temperature was reduced antil reaching 30N. Without stopping the stirring, 10 grams of the 25 pr osy prepared solution of estriol in glycerin we1m added, to obtain a 0.005% estrial formulation with the folIlowing -ComposiAtCion, Component...................................... . Amount [Neu PCL ow sei emlsa c To 1rear thgomlaini el (rmlim23 40 ilugo 3J Brnompol were Gl~solved .1n 88 ml of jur'L ^Led war~ev alN .2 g E Copoen Amount ...... . .... .. .. . .. .. . .. .... .... ......... ... V 11< ............. .... . ...... ..... ... ... .... . .... ...... ............ jp nle a e-M ..... ..... ..... .... .. ... .. --- -- - - - log'' ( ma ee pedU KKnnediK by .mcans t U agna elVage te an ee iend d5K)L}C stained with the Papaniolau technque The** efecH..:h eamnt. .. wit eaho Ktih fonvKnulatKin Ue) ieU))infat if orx th PC: i--. U ation findeC K e VagilK .I. K K UK and the ievau t he :.. K ouvetal t : :. Th resu L' a obtie ar-hw in t e lwigabe Day 0 Animal MI Cornified Overall ________C-B code B I C cells trophism Al A2 A3 A4 8 2 ... . . ...... . . ..-...... ... - - - ----------..... ............ B2 B 3 Day 5 Animal MI Cornified Overall C-B code B I C cells trophism Al J 6 A4 6 Y ... B..I. . . . ... .. ... ... .. .. B2 B43 B2r tn tt .. . . : ~ q ..... V Presence of cornified .H cells .. .... ... Overall trophism .> 1'7 . . .. . . . . . . . . . . . . oU~ L of O UMI 0 W eb 1C Sa tnn th Us L~w~y sed ada roess te vgna 1~y cn vo i h as K bt g~~~mvw,~~U th nemv fCriidadin m m ecls m matrskon nde euro<ii' pyopmed~~~~ I in te peen neton wl lo a hrp<' IJCW)h t m Cretn . . . . . . .. . .
Adl fml vretnsd Wsa ros h d. n 3' or the s a.. Y in "0 cnrled. 121"0 PotAri 13 / 2 It '3't da kn ss oilC Pl'o3 *asure'C " Thy wl e gie tnar it fr.as ed i 3' o l r , SU P ....- '-; He a <A'"' 3. arm N3' " C ~ '>'3'3'' d <AK libitum access to drikin wate (dikal 3ae o pb Gop P Al 2 K' tra te r w 1.t A RefaranC . ' n< Af lik C> '' C ' 3 ~ t 0000 animal a.-" 1q> '3>))') Tain 603 o wn n ad ?5-;a' A'' 'go' inC3 Ah A's "F 'C"" the3 re e a c ab tn o ( V o tn (" ' ''A J '3 Takin 60 '3 MY3mn Dd 30 g T r rtnN n aear: <'" A' As A'A 35 ) 3h n see to'' each Cnial of Gop3t ri , w eon a :<3' r -.- 1 A C'' ''> 3 ' r" 3 p E l V ec ive 2 '''tt e' 3 fer DA M A Gel -32; 0.02A 02 of es n Ai10qo gel /yr of KY.- 1,g c g&3 0.1 Ovsio of2 ustim mm 100 W 2x (J~ 2 ' ;r2 Thrfre ayK cie Mgeln G2 <'q es<,n 1. '2 25 212 m2' in 0 1 Z2et a . g n t o :V (2Gnro grou Li -lse hc a iA a m ~ a i. 3' h o k 5 oy d jn o v s tn *'a 2 AT t < 'W r 3 2,n<, th , uni2ma3ls, 2z &: - 36 phan <'2s 'I d y <"2 vo os M r ow nt o k I'''3'>. 01"z< '2' "< '3 I' 2'' '< 25' The <hi 'lns la t 1 & doy2 '2 - t2'3 2 3 Mim 2h 22(<t admnl ra mn222 W; W e a aK n 0'rqK SIM'a V<< ( 3 to Vo if 3 S me Pc~ )2 'on 2 L A9 mi 3'. 2 m,,u . PU Aden A! 3h "a2o 2A Kha 2<,ha 3nd th vaginal , < ; ''Kmh ym i an st lm 'w~a m to Mi '' C 3J~ 23, (;''< , ( ;~t >2' F! <s don of t" co nar3n ,a 32O a't :a 2< 5. <2 a~3 2< e/ 3 22o aaM 32 rs"2gr u . Th s;'ii tato I1 " Afte .ni pro ha elpetedsg iscan' dt weky diisrtin n l te GousAB ad H ".'O tro : Piaeh , 0.002 Gol n for 2 weeks health 1e**' of 2 w~ i changed ~ ~ ~ ~ ~ ~ ~ ~ .' ti a wokyamnsrto n l h ia ,fro, week.~' "73in NI eid o nta epne M Nrn 3 CoseU .V Anol a* vaia <7l i efr d i l h da ic'sv ) Carepnln 1 ha a'.nlhar3.q i 1 S' ..- hen Vn day i ,twet - y Yu1So e Fron tnis point onwrdz aia mey'r prond i 15 ap th arI '0 ' evry dv --- -------- > ~ -- 'Y4 i&t '
-------
~~iL~~~~I FI<21 T mi ~~Lt ~inh KTiT J- Nw 0 (N _ _ rlF H fLn in " F H0 N 4 ..... .. .i C.4FH Ti~~ (ijN{TiT [a W (0 rO 4 ... ----------- -- El H _ 4 ,C FN L T Fsaasc s 13 Mean values of the qualitative analysis organized by type of treatment and duration Arithm. Arithm. CONTROL mean PLACEBO mean Baseline 0.00 Baseline 0.00 2d 12 2d 180 3d 1 3d O 4d 16d 40 Ed l.4 d. 25d 100d 4d 40 6 3. 00 3d 240 3d 2.80 740 8d 41 00 16d 1.40 19d D 20 49 1.2 22d 1.022d1 25d 2501 2 10 28d 20 28d 1.0 312 0 31d 34 d . 0 346 100 37d Ge37d 0.40 40d .8 40d 0.40 43d 0.60 43d 0.20 46d D46l 08 0 49d D. 20 49d 20F0 14 Arithm; Arithm. Arithm, DOSE 1 mean DOSE 2 mean DOSE 3 mean Baseline 0.00 Baseline 0.00 Baseline 0.00 2d 2 00 2d 2 40 2d 2.80 3d 80 3d 3 00 3d J.00 4d 00 4d 00 4d 3.00 5d 5d 3 00 5d 3.00 60 6 0 6d 3.00 7d 3.00 7d 3,00 7d 3 00 8d 3 00 8d 3 00 8d 3 o0 16d 3.00 16d 3:0 16d now 19d 2 40 19d 0 19d 2.80 224 60 22d 22 .80 254 254 MCI0 25d 2,60 28d 2 0 28d 3.00 28d 3.00 31d 2.00 31d 2.60 31d 2.60 34d 60 34d 2 8 rj 0 34d 2 20. 37d 160 37d 2.20 37d 2 .60 40d 0 0 40d 2D 43d d,0 43d 1 42d 46d .60 46d 46d 1.40 49d 00 49d 1.60 49d 1.60 In he controL (silm u1aia o n and P 1a cebo groups Im a inLermedia te top of erect in Wise rved between days 2 and 8a good trophism be ng observed between days 4 and (ony nsmedays) Tn A increasemhve a ccmtr buto'n duo zo the Mechan ca ef fectofte cua cy oil sample taking, u<L as the subsequent r i n 0 ~ i Aor due to a "habituation" ordeenitzaio to said mhanical effect as nas beeni obsrvd n peiu tde seet Tables 8 and 9) , n ti grop S o w 1h i h s Ubsj t ancs w th estr ie are 115 obere bew e 4an 2 nd 3 . Fom ciS P iiU p, raphY onadn wJ 1 te So of Ae difernt asay UN e Fe v n susane (day .3 6 wa h.at3yo ~nita o in 4sTeeoevr A~aMP ohv anlto ver low doe f.t3' w~ gposbet~ r e rvn ig teUIrc s f Y':' /3rolni a '4G h ndp o i in : A '.3 71 ~'~c>~KF c H 4) Co< ~ N >t 0 V ..t- ... ..... ..... .. .. H H I Hr o C 1c :vL M5 a -'! Wi N -1 'C aND EaVcTIao 17 Mean values of the quantitative analysis organized by type of treatment and duration CONTROL Arithm. mean PLACEBO Arlthm. mean Baseline -92 jO Baseline 2d -i400 2d -10.0 3d -08.00 3d -G >0 4d 18.00 4d 6.00 5d 18.0>0 5d -22>00 6d -600 6d 34.00 7d 18080 7d 22>00 Sd 22.00 Sd -6200 16d -6>00 16d -22, 0 19d -4 <00 19d -34 00 22d 40 ( 22d -4>,00 25d - "00 25d -0 00 28d -2 28d -42>00 31d -50 31d -48000 34d -54 34d ~70>00 37d - >, 00 37d --- 2 00 40d -72 %0 40d -80000 43d 7- 7600 43d -84>00 46d -7 61 46d -7200 49d 80 49d -0600 Ari thm. Ar. thm Arithm, DOSE I Mean DOSE 2 DOSE 3 Baseline Baseline 94 Baseline 96.00 2d 2d 2600 2d 42 3d 8 3d 42, 3d 4d620 4d 4d 50.00 5d 48,0 5d 46,0 5d 6400 6d 6 6d 0 d 6 7d 50 0 7d 5C, 7d 862. 86 ,, d '7400 16d 5.0- 16d 16d 0 19d 1 19d 19d 40 22d 226 -0 b 22d 48 25d 25d 0 25d 2.0 28d 28d . 28d 31d *-6O 31d 22.00 31d 2 o 34d -2600 34d 34d 37d -18 0 376 0 37d 40d 4. 0 0 40d 402 43d 0 0 43d 43d 2 46d 0D 46d 6 46d 49d -0 0 49d 49d The reut sa ar v N e C tt se J. to K K I c n r ( im io d p br s id Fow b Cw e d a go bing bsem d s 4 hiKs eKrsrae w t t' m ap erac y administration until day 15. Afterwards, a fluctuation between good trophism and intermediate arophisn is observed, resulting in an ineredatea trophis macition Froma day 37 of the ntudy (day 36 was the last day Of admilnisr.raton, reaching a hyaO-crph.nc nio fccm day 40, The rest of the gro mmups airing estrial (dos> 2 (0,l pg estriol) and dose 3 (2.9 pg estrici . have a similar 10 36. On day 37 for dose 3 there is good tropasm whereas for dose 2 there is intermediate trhpism In dose 2 a hypotrophy condition is acquired one day smaor than fr done 3.

Claims (7)

1.- Use of estriol in the preparation of a pharmaceutical composition for vaginal administration for the prevention and/or the treatment of urogenital atrophy due to estrogen deficit in 5 women, wherein said composition is administered such that the patient receives a dose of estriol less than or equal to 0.3 mg/day and wherein the administration is daily or in a regimen of once every two days, once every three days or once a week, for at least 3 weeks. 10
2.- Use according to claim 1, wherein the patient receives a dose of estriol less than or equal to 0.1 mg/day.
3.- Use according to claim 1, wherein the patient receives 15 a dose of estriol between 0.002 and 0.05 mg/day.
4.- Use according to claim 1, wherein the patient receives a dose of estriol between 0.02 and 0.05 mg/day. 20 5.- Use according to any of the previous claims, wherein the administration is daily for at least 3 weeks.
6.- Use according to claim 5, wherein the administration is daily for at least 30 days. 25
7.- Use according to claim 5, wherein the administration is daily for at least 60 days.
8.- Use according to claim 5, wherein the administration is 30 daily for at least 90 days.
AU2008269683A 2007-06-25 2008-06-25 Use of estriol in low doses Active AU2008269683B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
ESP200701755 2007-06-25
ES200701755A ES2310968B1 (en) 2007-06-25 2007-06-25 USE OF ESTRIOL IN LOW DOSE.
PCT/ES2008/000450 WO2009000954A2 (en) 2007-06-25 2008-06-25 Use of estriol in low doses

Publications (2)

Publication Number Publication Date
AU2008269683A1 AU2008269683A1 (en) 2008-12-31
AU2008269683B2 true AU2008269683B2 (en) 2013-06-06

Family

ID=40186085

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2008269683A Active AU2008269683B2 (en) 2007-06-25 2008-06-25 Use of estriol in low doses

Country Status (14)

Country Link
US (1) US8273730B2 (en)
EP (2) EP2158914A4 (en)
JP (1) JP5623273B2 (en)
KR (1) KR20100036337A (en)
CN (2) CN104739842A (en)
AU (1) AU2008269683B2 (en)
BR (1) BRPI0813947A2 (en)
CA (1) CA2689335C (en)
CO (1) CO6251259A2 (en)
EC (1) ECSP099826A (en)
ES (2) ES2310968B1 (en)
MX (1) MX2009013427A (en)
RU (1) RU2483734C2 (en)
WO (1) WO2009000954A2 (en)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2344673B1 (en) * 2008-08-07 2011-05-03 Italfarmaco, S.A. USE OF ESTRIOL IN THE PREPARATION OF A PHARMACEUTICAL FORMULATION FOR THE TREATMENT OF VAGINAL ATROPHY IN WOMEN WITH RISK OF POTOLOGIATUMORAL.
ES2344675B1 (en) * 2008-12-19 2011-04-28 Italfarmaco, S.A. USE OF ESTRIOL IN THE PREPARATION OF A PHARMACEUTICAL FORMULATION FOR THE TREATMENT OF VAGINAL ATROPHY IN WOMEN WITH RISK OF VARIUM VARCOLOGY.
US8817769B2 (en) 2009-01-26 2014-08-26 Qualcomm Incorporated Power decision pilot for wireless communication
US9301920B2 (en) 2012-06-18 2016-04-05 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
LT2782584T (en) 2011-11-23 2021-09-10 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US20150196640A1 (en) 2012-06-18 2015-07-16 Therapeuticsmd, Inc. Progesterone formulations having a desirable pk profile
US10806740B2 (en) 2012-06-18 2020-10-20 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US10806697B2 (en) 2012-12-21 2020-10-20 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US20130338122A1 (en) 2012-06-18 2013-12-19 Therapeuticsmd, Inc. Transdermal hormone replacement therapies
US11266661B2 (en) 2012-12-21 2022-03-08 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US11246875B2 (en) 2012-12-21 2022-02-15 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10537581B2 (en) 2012-12-21 2020-01-21 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10471072B2 (en) 2012-12-21 2019-11-12 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10568891B2 (en) 2012-12-21 2020-02-25 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US9180091B2 (en) 2012-12-21 2015-11-10 Therapeuticsmd, Inc. Soluble estradiol capsule for vaginal insertion
CN103405294A (en) * 2013-08-02 2013-11-27 苏州市马尔泰新材料有限公司 Diethylstilbestrol-containing vaginal stent
CN103393488A (en) * 2013-08-02 2013-11-20 苏州市马尔泰新材料有限公司 Vagina mold containing estriol
CN103357074A (en) * 2013-08-02 2013-10-23 苏州市马尔泰新材料有限公司 Sustained-release mold preparation material
CN103394130A (en) * 2013-08-13 2013-11-20 苏州市马尔泰新材料有限公司 Die material containing estrol and Szechwan lovage rhizome
AU2015264003A1 (en) 2014-05-22 2016-11-17 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US10328087B2 (en) 2015-07-23 2019-06-25 Therapeuticsmd, Inc. Formulations for solubilizing hormones
US10286077B2 (en) 2016-04-01 2019-05-14 Therapeuticsmd, Inc. Steroid hormone compositions in medium chain oils
WO2017173071A1 (en) 2016-04-01 2017-10-05 Therapeuticsmd, Inc. Steroid hormone pharmaceutical composition
US11633405B2 (en) 2020-02-07 2023-04-25 Therapeuticsmd, Inc. Steroid hormone pharmaceutical formulations

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1866M (en) 1961-04-07 1963-06-17 Vismara Francesco Spa New ethers of estrogen hormones.
US5543150A (en) 1993-09-15 1996-08-06 Columbia Laboratories, Inc. Method of progesterone delivery and affect thereof
AT408067B (en) 1995-03-17 2001-08-27 Gebro Pharma Gmbh PHARMACEUTICAL COMPOSITION FOR TOPICAL APPLICATION AND METHOD FOR THE PRODUCTION THEREOF
US5942243A (en) 1996-11-12 1999-08-24 Polytherapeutics, Inc. Mucoadhesive compositions for administration of biologically active agents to animal tissue
DE19917930A1 (en) * 1999-04-15 2000-10-19 Schering Ag Treating estrogen deficiency associated disorders, e.g. menopausal problems, osteoporosis, neoplasia or neurodegenerative disease, using new or known ent-steroids having bone-selective estrogenic activity
AR030312A1 (en) 2000-08-03 2003-08-20 Antares Pharma Ipl Ag NEW COMPOSITION FOR THE TRANSDERMAL AND / OR TRANSMUCOSICAL ADMINISTRATION OF ACTIVE COMPOUNDS, WHICH ENSURES PROPER THERAPEUTIC LEVELS
ES2237298B1 (en) 2003-07-16 2006-11-01 Italfarmaco, S.A. SEMISOLID MUCOADHESIVE FORMULATIONS.
RU2268726C2 (en) * 2004-03-30 2006-01-27 ГУ "Научно-исследовательский институт экспериментальной медицины" РАМН (ГУ НИИЭМ РАМН) Method for treating affected amnestic functions
CA2637608A1 (en) * 2006-01-20 2007-07-26 Pear Tree Pharmaceuticals, Inc. Method of treating atrophic vaginitis

Also Published As

Publication number Publication date
ES2310968A1 (en) 2009-01-16
EP4335501A2 (en) 2024-03-13
BRPI0813947A2 (en) 2014-12-30
CA2689335C (en) 2018-01-23
ES2310968B1 (en) 2010-02-08
EP2158914A2 (en) 2010-03-03
ES2693085T1 (en) 2018-12-07
US20090318401A1 (en) 2009-12-24
EP4335501A3 (en) 2024-05-15
JP5623273B2 (en) 2014-11-12
US8273730B2 (en) 2012-09-25
WO2009000954A3 (en) 2009-02-12
RU2009148278A (en) 2011-06-27
MX2009013427A (en) 2010-07-30
AU2008269683A1 (en) 2008-12-31
CN104739842A (en) 2015-07-01
CO6251259A2 (en) 2011-02-21
KR20100036337A (en) 2010-04-07
ECSP099826A (en) 2010-04-30
RU2483734C2 (en) 2013-06-10
CN101702879A (en) 2010-05-05
JP2010531302A (en) 2010-09-24
WO2009000954A2 (en) 2008-12-31
EP2158914A4 (en) 2010-06-30
CA2689335A1 (en) 2008-12-31

Similar Documents

Publication Publication Date Title
AU2008269683B2 (en) Use of estriol in low doses
Hamill et al. Traditional herbal drugs of Southern Uganda, II: literature analysis and antimicrobial assays
JP4312402B2 (en) Anti-depressant, anti-menopausal agent, anti-senile dementia agent, anti-Alzheimer agent
Rahman et al. Medicinal plants used by Chakma tribe in Hill Tracts districts of Bangladesh
JP4609875B2 (en) healthy food
AU686656B2 (en) Compositions containing piperine
Carag et al. A checklist of the orders and families of medicinal plants in the Philippines
RU2000109723A (en) COMPOSITION AND METHOD FOR REDUCING LOW DENSITY LIPOPROTEIN CHOLESTEROL CONCENTRATION
JP5345778B2 (en) Use of pregnane glycosides in the treatment / management of obesity, obesity related disorders, and other disorders
CN103432287B (en) Camellia oleosa seed lavipeditum powder and preparation method thereof
CA2395016C (en) Treatment of dna viral infections
Mosisa Gudeta et al. Evaluation of anti-diarrheal activity of 80% methanol extracts of vernonia amygdalina delile (asteraceae) leaves in mice
CN101156863B (en) A medicine composition for treating cardiac and cerebral vascular disease and its medical usage
CN110151829A (en) A kind of external application delay agent improving male&#39;s sexual life time
CN101129395A (en) Traditional Chinese medicine active ingredient composition for treating cardiovascular disease and use thereof
CN106822579A (en) Composition with treatment osteoporosis effect and its preparation method and application
CN101156688A (en) Health food for sleep-regulating function and its preparation method
Gilani et al. Cholinomimetic and calcium channel blocking activities of Carthamus oxycantha
CN101549098A (en) Pandan leaf extract for treating gout and preparation method thereof
Hedaoo et al. Advantages of natural diuretics over synthetic diuretics as a part of treatment
JP2005278604A (en) Healthy food
Khatun et al. Taxonomic diversity of broad-leaf weeds at Bangladesh Agricultural University campus and their ethno-botanical uses.
JP2005289817A (en) Anticancer agent
Shatarat et al. Effects of beta-carboline alkaloids of Peganum harmala on induced rat ileum contractions
Arora et al. Ashwagandha: A Flagship Herb of Ayurveda from Past to Present Nano Era.

Legal Events

Date Code Title Description
PC1 Assignment before grant (sect. 113)

Owner name: ITF RESEARCH PHARMA, S.L.U.

Free format text: FORMER APPLICANT(S): ITALFARMACO, S.A.

FGA Letters patent sealed or granted (standard patent)